Job Title: Head of QA Ops, APU 11 Forbes
- Location: Northborough, MA
About the JobThe Head of Quality Assurance Operations is responsible for overseeing and managing all quality and compliance activities within the manufacturing facility, ensuring compliance with regulatory requirements, GMP standards, and organizational quality objectives. This role plays a critical part in maintaining product quality, driving continuous improvement, and leading a high-performing Quality team.
Main Responsibilities- Batch Review & Disposition: Review and prepare batch disposition for all intermediates and finished goods manufactured within the assigned area. Final accountability resides under the QAP (Qualified Authorized Person, or equivalent) depending on local regulations.
- Regulatory Readiness: In case of specific regulations linked to the area (e.g., Device, MTI), ensure readiness for inspection by national and international agencies through implementation of corresponding specific requirements.
- Annual Quality Objectives: Develop and implement annual quality assurance operation objectives in alignment with the organizational strategy, vision, and objectives.
- Quality Procedures: Develop and implement quality operation procedures supporting the proper execution of manufacturing activities.
- Compliance & Risk Management: Maintain a system to ensure compliance and quality risks are properly identified, tracked, and mitigated.
- Quality Event Closure: Ensure the timely closure of quality events such as deviations, CAPAs, and change controls to maintain compliance and operational efficiency.
Key Involvement in Decision-Making Process:- Accountable (A): Review and prepare manufacturing documentation for batch disposition by QAP
- Decision Maker (D): Define initiatives to improve quality assurance operation processes and systems
- Accountable (A): Identify and escalate possible quality alert risks, Provide support to quality control processes and improvements.
- Informed (I): Follow progress on quality improvement projects and initiatives, Proactively implement remediation actions from findings of internal and external audits related to quality assurance operations.
Detailed Responsibilities:- Manufacturing Process Oversight: Oversee the entire manufacturing process to ensure that all steps are validated and adhere to Standard Operating Procedures (SOPs).
- Metrics & Monitoring: Establish metrics and monitor data for quality assurance operation activities to identify trends and issues, and implement action plans accordingly.
- KPI Management & Reporting: Establish and monitor key performance indicators (KPIs) and metrics for the quality assurance operation, and report regularly on performance and effectiveness.
- Quality Culture Promotion: Promote a culture of quality throughout the quality assurance operation organization within the assigned area of responsibility.
- Continuous Improvement: Identify and drive continuous improvement initiatives and projects to enhance quality assurance operation efficiency and effectiveness, fostering a culture of continuous improvement.
- Innovation & Technology: Evaluate and recommend new technologies, tools, and methods, and promote innovation to enhance quality assurance operation processes and outcomes.
- Management Reviews: Lead management reviews to assess the effectiveness of the quality assurance operation and implement necessary adjustments.
- Team Leadership: Lead and manage the quality assurance operation team, including hiring, training, coaching, professional development, and performance evaluation.
About YouBasic Qualifications- Bachelor's Degree in Life Sciences or related fields with 8+ years of experience in quality functions.
- OR Master's Degree with 6+ years of experience.
Preferred Qualifications- Experience in the pharmaceutical, biotechnology, biologics, cell and gene therapy, or other regulated industries.
- Experience in Drug Product Manufacturing
- Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles
- Ability to analyze complex data and identify trends, issues, and solutions
- High level of accuracy and attention to detail in all quality assurance activities
- Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
Expected Technical Skills:- Inspection Management Experience at a Drug Product Manufacturing Site
- Proficiency in identifying problems and implementing effective corrective actions
- Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards
- English proficiency required.
Why choose us?- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation - at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
The salary range for this position is:
$133,500.00 - $192,833.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
